CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that the Food and Drug Administration (FDA) granted its subsidiary Xeris Pharmaceuticals, Inc., orphan-drug exclusivity (ODE) for Recorlev® (levoketoconazole) for the treatment of adult patients with endogenous Cushing’s syndrome for whom surgery is not an option or has not been curative.
CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today announced that Recorlev® (levoketoconazole) is now available for prescription. The U.S. Food and Drug Administration (FDA) approved Recorlev on December 31, 2021 for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.
CHICAGO--(BUSINESS WIRE)--XerisnBiopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company ndeveloping and commercializing unique therapies for patient populations nin endocrinology, neurology, and gastroenterology, today announced the nU.S. Food and Drug Administration (FDA) approval of Recorlev®n(levoketoconazole) for the treatment of endogenous hypercortisolemia innadult patients with Cushing’s syndrome for whom surgery is not an noption or has not been curative.1
DUBLIN, Ireland and TREVOSE, Pa., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today reported financial results for the third quarter of 2020 and provided a corporate update.
Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today provided a corporate update, including the announcement of positive and statistically significant top-line results from the Phase 3 LOGICS study.
DUBLIN, Ireland and TREVOSE, Pa., July 01, 2020 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that the last participant has completed the last study visit in the randomized withdrawal phase of the LOGICS study for RECORLEV® (levoketoconazole), its product candidate for the treatment of endogenous Cushing’s syndrome. A total of 43 patients completed the randomized withdrawal phase of the study.
DUBLIN, Ireland and TREVOSE, Pa., May 20, 2020 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that it and its subsidiaries have entered into a $30 million debt facility with Avenue Venture Opportunities Fund, L.P. (Avenue), a fund within the Avenue Capital Group, and its affiliates.